NCT03401229

Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.

Conditions

• Nasal Polyposis

Interventions

Type	Name	Description
BIOLOGICAL	Benralizumab 30 mg SC + Mometasone Furoate	Benralizumab injection is 30mg/ml SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe. Benralizumab 30 mg SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses. Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study.
BIOLOGICAL	Matching placebo SC + Mometasone Furoate	Matching placebo injection is SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe. Matching placebo SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses. Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study.

Timeline

• Start date: 2018-01-15
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2018-01-17
• Last updated: 2021-10-12
• Results posted: 2021-10-12

Locations

99 sites across 8 countries: United States, Austria, Belgium, Canada, Denmark, Germany, Hungary, Poland

Regulatory

• FDA-regulated drug study